KD-556J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

Device Description

It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also calculates the average of the last three measurements.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the KD-556J Fully Automatic Electronic Blood Pressure Monitor:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy ranges for blood pressure measurements) for the KD-556J. Instead, it relies on the device's conformance to established industry standards like ANSI/AAMI SP10 for safety and performance. The primary "performance" reported is its substantial equivalence to a predicate device.

Acceptance Criteria (Implied by Standards Conformance & Equivalence)	Reported Device Performance
Safety and performance characteristics according to ANSI/AAMI SP10 (Manual, electronic, or automated sphygmomanometers)	"The subject device KD-556J is identical to its predicate device KD-556... The clinical test report of KD-556(K091500) is applicable to our subject device." "None of the test demonstrates that KD-556J bring new questions of safety and effectiveness." "KD-556J Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards: ... AAMI SP10:2002, AAMI / ANSI SP10:2002/A1:2003, AAMI / ANSI SP10:2002/A2:2006"
Electromagnetic compatibility (EMC) according to IEC 60601-1-2	"Electromagnetic compatibility evaluation according to IEC 60601-1-2" was done. "conforms to the following standards: ... EN 60601-1-2, Medical Electrical Equipment Part 1-2..."
Electrical safety according to IEC 60601-1	"Electrical safety test according test to IEC 60601-1" was done. "conforms to the following standards: ... IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety..."
Non-raising of new questions of safety and effectiveness compared to predicate device	"However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness to the new devices."
Substantial equivalence to predicate device KD-556 (K091500)	"Our device KD-556J Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-556 whose 510(k) number is K091500."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document states, "The clinical test report of KD-556(K091500) is applicable to our subject device." This implies that no new clinical test was performed for the KD-556J. The sample size for the original KD-556 (K091500) clinical test is not provided in this document.
Data Provenance: The provenance of the data for KD-556 is not specified in this document (e.g., country of origin). Since it's referencing a prior 510(k) submission, that information would likely be found in the K091500 documentation. It's also not specified whether the original clinical study for KD-556 was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Number of Experts: Not specified. As no new clinical study was performed for KD-556J, and the document refers to the predicate device's clinical report, details about experts for the ground truth of the original study are not present here.
Qualifications of Experts: Not specified Lehmann.

4. Adjudication Method for the Test Set:

Adjudication Method: Not specified. This information would have been part of the original clinical study for KD-556, which is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic imaging tool where MRMC studies are typically employed to assess human reader improvement.
Effect Size: Not applicable, as no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Standalone Performance: Yes, implicitly. The device itself is a "Fully Automatic Electronic Blood Pressure Monitor" designed to measure and display blood pressure and pulse rate without human intervention beyond placing the cuff and starting the measurement. Its performance is evaluated against the standards (AAMI SP10), which define accuracy requirements for such standalone devices. The non-clinical tests (EMC, electrical safety, SP10 compliance) and the reliance on the predicate's clinical data affirm its standalone nature.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

Type of Ground Truth: The document refers to compliance with ANSI/AAMI SP10. This standard specifies the methodologies for determining the accuracy of blood pressure measurement devices. For such devices, the "ground truth" is typically established by simultaneous or near-simultaneous measurements using a reference method (e.g., auscultation by trained observers using a mercury sphygmomanometer), following a specific protocol to minimize bias and observer error. This is a form of expert consensus/reference standard comparison, but the document does not explicitly state the specific method used for the predicate study.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This device is an electronic blood pressure monitor based on oscillometric technology and silicon integrated pressure sensor technology, not a machine learning or AI-based device that typically requires a "training set" in the context of deep learning or similar algorithms. The term "training set" is generally used for AI/ML model development.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set: Not applicable, as there is no "training set" in the AI/ML sense for this device.

Summary

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16 1103

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

1.0 submitter's information

FEB 1 8 2011

Name:	Andon Health Co., Ltd.
Address:	No 3, Jinping Street Ya An Road, Nankai District, Tianjin, P.R. China
Phone number:	86-22-6052 6161
Fax number:	86-22-6052 6162
Contact:	Liu Yi
Date of Application:	01/27/2011

2.0 Device information

Trade name:	Fully Automatic Electronic Blood Pressure Monitor
Common name:	Noninvasive blood pressure measurement system
Classification name:	Noninvasive blood pressure measurement system

3.0 Classification

Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Panel: Cardiovascular

4.0 Predicate device information

Manufacturer: Andon Health Co., Ltd.

KD-556 Fully Automatic Electronic Blood Pressure Device: Monitor
510(k) number: K091500

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5.0 Device description

16110330

It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.

6.0 Intended use

The intended use and the indication for use of KD-556J, as described in the labeling are the same as their predicated device KD-556.

device
Technological Characteristics	Comparison result
Design principle	Identical
Appearance	Similar
Patients contact Materials	Identical
Performance	Similar
Biocompatibility	Identical
Mechanical safety	Identical
Energy source	Identical
Standards met	Identical
Electrical safety	Identical
EMC	Identical
Function	Similar

7.0 Summary_comparing_technological_characteristics_with_predicate device

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8.0 Discussion of non-clinical and clinical test performed

Non-clinical Tests have been done as follows:

a. Electromagnetic compatibility evaluation according to IEC 60601-1-2;
b. Electrical safety test according test to IEC 60601-1 ;
c. Safety and performance characteristics of the test according to SP10

None of the test demonstrates that KD-556J bring new questions of safety and effectiveness.

Clinical Test Concerning the Compliance of ANSI/AAMI SP10

From the technical point of view, the subject device KD-556J is identical to its predicate device KD-556. The difference between the subject device and its predicate devices do not affect the clinical accuracy in terms of blood pressure detection. The clinical test report of KD-556(K091500) is applicable to our subject device.

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9.0 Performance summary

KD-556J Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:

IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
· EN 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007.
· AAMI SP10:2002, Manual, electronic or automated sphygmomanometers.
· AAMI / ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.

10.0 Comparison to the predicate device and the conclusion

Our device KD-556J Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-556 whose 510(k) number is K091500.

KD-556J is very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards. Only the appearance, the time format and the hypertension classification of KD-556J is changed. KD-556J will use the JNC hypertension classification while its predicate device KD-556 uses the WHO hypertension classification.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness to the new devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 1 8 201

Andon Health Co., Ltd. c/o Mr. Liu Yi President No. 3, JinPing Street, Ya An Road, Nankai District Tianjin, P.R. China, 300190

Re: K110330

Trade/Device Name: KD-556J Fully Automatic Electronic Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement systems Regulatory Class: Class II (two) Product Code: DXN Dated: January 31, 2011 Received: February 3, 2011

Dear Mr. Yi:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & nave and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreat 1976, the enactment date of the Medical Device Amendments, or to econmores that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). Tou may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefer your of the Act include requirements for annual registration, listing of general voltren provincities, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it · If your device is classified (500 above) Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of Features concerning your device in the Federal Register.

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Page 2 – Ms. Liu Yi

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

W.M.S.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number :	K110330
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Device name: KD-556J Fully Automatic Electronic Blood Pressure Monitor

Indications for use:

KD-5561 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

Prescription use Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR YES (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W. Wtast.

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).